FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer
K Number: K171971
·
Decision Jan 25, 2018
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
123
Applicant Total
1
Review Days
209
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Basic Information
- Device Name
- Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer
- K Number
- K171971
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lite-On Technology Corp. H.S.P.B.
- Date Received
- June 30, 2017
- Decision Date
- January 25, 2018
- Product Code
- CJE
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | FDA class 2 | Clinical Chemistry |
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